Laboratory Chemical Technology- Temporary Assignment (Six (6) months)

The incumbent is accountable for performing chemical (analytical) analysis of formulations and packaging solutions for lens in a small manufacturing scale (piloting lab) in the Innovation Center Chemical Laboratory to support new process development, new product introduction and investigations. During the performance of responsibilities, the incumbent must comply with the Good Laboratory Practices (GLP), QSR and ISO 13485, safety and environmental regulations.

Essential Functions & Accountabilities:
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Performs chemical and physico-chemical analysis of lenses (dry and wet), and packaging solutions related to investigations, validations, engineering studies, formulation changes, stability, troubleshooting, projects, and new developments.
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Prepares lens samples, labels and required documentation to send samples for clinical testing and/or in-vitro testing as per established procedures.
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Generates and/or reviews protocols and necessary documentation for Engineering studies and validations in addition to execute validation protocols and studies.
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Approves changes and documents through the company Agile (eQMS) platform.
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Generates and participates in laboratory investigations.

Provides support to Manufacturing Incoming Laboratory, Analytical laboratory, and QA Laboratory on raw materials and formulations’ chemical analysis (i.e. monomers residuals, monomer mix, alcohol purity testing and impurity testing) as required.
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Maintains laboratory equipment in optimal conditions:
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Performs periodical checks of laboratory equipment to maintain proper operation.
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Performs minor troubleshooting and maintenance to laboratory equipment.
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Coordinates equipment preventive maintenance, repair and calibrations with the service external supplier.
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Maintains well organized the raw materials and products in the lab freezer and storage areas.
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Maintains the inventory of equipment, standards of stock solutions, general lab supplies (i.e. helium gases), verifying their expiration dates.
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Requests quotes to providers and generates requisition (through the Electronic Requisition System) to ensure equipment / materials inventory availability as needed.
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Coordinates the disposal of any unused and/or contaminated materials.
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Monitors laboratory temperature and storage temperature for all the materials and the stability chambers.
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Ensures that all laboratory documentation is in compliance according to Good Documentation Practices (e.g. perform by / verify by) and, records daily laboratory activities in the laboratory notebook.
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Assists Senior Scientist with laboratory trending reports.
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Provides support with department new hires (Engineers, Lab Tech e.g.) training on Company’s Laboratory Chemical Analysis SOPs.
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Cleans laboratory glassware and equipment used as part of chemical analysis.
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Complies with all ETR (Electronic Training required) required trainings.
Quality System Responsibilities
•Safety & Occupational Health Responsibilities
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Complies with Safety and Occupational Health Policy and procedures.
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Complies with Hazardous Communication program.
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Notifies immediately all accidents or incidents occurred in work area.
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Complies with the usage, inspection and maintenance of the personal protective equipment required, if applicable.
Complies with the Quality System Regulation (QSR).
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Executes job responsibilities as established in the Standard Operating Procedures (SOP).
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Follows the documentation procedures.
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Completes training for the qualification and certification, as required, to execute the job.

Qualifications
Knowledge, Skills, and Abilities:
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Knowledge in Quality System Regulation (QSR), Good Laboratory Practices (GLP) and ISO 13485
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Able to work with minimum supervision
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Problem Solving and initiative skills
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Good oral and written communication skills English and Spanish
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Good skills of sampling techniques
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Good skills of chemical laboratory methods and techniques
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Good analytical chemical concepts skills
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Good mathematics skills
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Basic computer skills (i.e. Excel, Word, PowerPoint)
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Ability to read and understand instructions in two languages, English and Spanish
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Dynamic and self-starter
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Uses communication skills to work in a team environment.
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Able to apply analytical skills.
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Able to work with computers.
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Able to troubleshoot processes and equipment.

Interpersonal:
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Highly motivated and initiative
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Accurate and thoroughness

Experience:
•Three (3) years industrial experience in medical device, chemical or pharmaceutical industries in a quality assurance laboratory or equivalent experience.
•Experience mixing, and analytical laboratories.
•Experience in analytical techniques and analytical equipment operation (HPLC, GC, GPC, FT-IR, UV-Visible, Karl Fisher, pH Meter, conductivity meter, colorimeter, and osmometer).
 

Education:
•Bachelor Degree in Sciences with major in Chemistry